A Phase II Study of Intravenous Rexin-G in Recurrent or Metastatic Osteosarcoma
The adaptive trial design of this advanced Phase II study incorporates (i) a dosing schedule
based on the patient's estimated tumor burden and not on standard dosing per kilogram body
weight or body surface area, and (2) a tumor response evaluation process that is unique to
the manner in which osteosarcoma responds favorably to therapy, i.e., with necrosis and
increasing calcification in metastatic tumors and decreased glucose utilization using PET-CT
Twenty to thirty patients will receive Rexin-G at either Dose Level 1 or 2. Patients will be
assigned a dose level based on the estimated tumor burden as measured by PET-CT imaging
studies. Estimated tumor burden is measured by multiplying the sum of the longest diameters
of target lesions in cm by 10e9 cancer cells. If the tumor burden is less than 10 billion
cells, the patient will be assigned to Dose Level 1, if the tumor burden is greater than 10
billion cells, the patient will be assigned to Dose Level 2.
*Treatment Cycle Dose Level Vector Dose/Day Max.Volume/Dose
Two times a week 1 1.0 x 10e11 cfu 200 ml
Three times a week 2 1.0 x 10e11 cfu 200 ml
* Each treatment cycle will be six weeks (four weeks of treatment and two weeks of rest).
Patients who have resolution of toxicity to < grade I may have repeat cycles. After one or
more treatment cycles, the principal investigator may recommend surgical debulking or
complete surgical removal. If residual disease is present either by histopathological
examination or by PET-CT scan, repeat treatment cycles may be given 3-4 weeks after surgery,
if the surgical incision has healed, and if the patient has < grade I toxicity.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical efficacy as measured by over-all response rates (either CR, PR or SD) by International PET criteria
Sant P Chawla, M.D.
Epeius Clinical Research Unit/Sarcoma Oncology Center
United States: Food and Drug Administration
|Epeius Clinical Research Unit/Sarcoma Oncology Center||Los Angeles, California 91108|